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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORIGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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BOSTON SCIENTIFIC CORPORATION ORIGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D Back to Search Results
Model Number G050
Medical Device Problem Code High impedance (1291)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/11/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) with right atrial competitor lead displayed pacing lead impedances greater than 3000 ohms.The sensing and threshold measurements remained stable during pocket manipulation testing and no artifacts were seen.The physician elected to reprogram the crt-d from vdd to ddd and to follow up with patient in three month intervals.The device remains in service.No adverse patient effects were reported.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
 
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Brand Name
ORIGEN CRT-D
Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key9972924
Report Number2124215-2020-07767
Device Sequence Number19358139
Product Code NIK
UDI-Device Identifier00802526534454
UDI-Public00802526534454
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
P010012/S341
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date01/02/2020
Device Model NumberG050
Device Catalogue NumberG050
Device Lot Number489209
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/11/2020
Initial Report FDA Received Date04/17/2020
Patient Sequence Number1
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